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Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05988528
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : August 23, 2023
Sponsor:
Information provided by (Responsible Party):
Mostafa Bahaa, Tanta University

Study Description
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Brief Summary:

Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life.

Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Drug: Mesalamine Drug: Nifuroxazide Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: double blinded
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis
Actual Study Start Date : August 20, 2023
Estimated Primary Completion Date : August 20, 2027
Estimated Study Completion Date : November 20, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: control group
Control group (Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months
 Drug: Mesalamine
Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis.
Active Comparator: Nifuroxazide group
Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times daily for 6 months
 Drug: Mesalamine
Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis.

Drug: Nifuroxazide
Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint is the improvement in health-related quality of life [ Time Frame: 6 months ]
    The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Both male and female will be
  • Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

  • Breast feeding
  • Significant liver and kidney function abnormalities
  • Colorectal cancer patients
  • Other inflammatory bowel diseases (CD).
  • Patients with severe UC
  • Patients taking rectal or systemic steroids
  • Patients taking immunosuppressives or biological therapies
  • Addiction to alcohol and / or drugs
  • Known allergy to the Fenofibrate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05988528


Contacts
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Contact: Mostafa Bahaa, PhD 0201025538337 mbahaa@horus.edu.eg

Locations
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Egypt
Tanta University Recruiting
Tanta, Egypt
Contact: Wala A Negm, Dr       walaa.negm@pharm.tanta.edu.eg   
Sponsors and Collaborators
Mostafa Bahaa
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mostafa Bahaa, Teaching assisstant, Tanta University
ClinicalTrials.gov Identifier: NCT05988528    
Other Study ID Numbers: 8/2023
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Nifuroxazide
Mesalamine
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Infective Agents